tirzepatide · Eli Lilly And Co · NDA 215866
Mounjaro (Autoinjector)
Earliest generic entry, as listed · earliest of 6 marketed strengths
30 Dec 2041
Blocked by patent: US 12295987, US 12295987. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 28 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12295987 | use U-4192 | 30 Dec 2041 |
| US 12295987 | use U-4193 | 30 Dec 2041 |
| US 12343382 | use U-4232 | 22 Jul 2039 |
| US 12343382 | use U-4229 | 22 Jul 2039 |
| US 12343382 | use U-4230 | 22 Jul 2039 |
| US 12343382 | use U-4231 | 22 Jul 2039 |
| US 12343382 | use U-4400 | 22 Jul 2039 |
| US 12343382 | use U-4401 | 22 Jul 2039 |
| US 12616740 | use U-4501 | 22 Jul 2039 |
| US 12616740 | use U-4502 | 22 Jul 2039 |
| US 12616740 | use U-4500 | 22 Jul 2039 |
| US 11357820 | product | 14 Jun 2039 |
| US 12453755 | use U-4384 | 14 Jun 2039 |
| US 12453755 | use U-4375 | 14 Jun 2039 |
| US 12453755 | use U-4376 | 14 Jun 2039 |
| US 12453755 | use U-4377 | 14 Jun 2039 |
| US 12453755 | use U-4378 | 14 Jun 2039 |
| US 12453755 | use U-4379 | 14 Jun 2039 |
| US 12453755 | use U-4380 | 14 Jun 2039 |
| US 12453755 | use U-4381 | 14 Jun 2039 |
| US 12453755 | use U-4382 | 14 Jun 2039 |
| US 12453755 | use U-4383 | 14 Jun 2039 |
| US 12453755 | use U-4385 | 14 Jun 2039 |
| US 12453755 | use U-4386 | 14 Jun 2039 |
| US 12453756 | product | 14 Jun 2039 |
| US 12629404 | product, use U-4533 | 14 Jun 2039 |
| US 12629404 | product, use U-4534 | 14 Jun 2039 |
| US 9474780 | substance, product, use U-4374 | 13 May 2036 |
Exclusivities · 2 unexpired
| NPP | new patient population | 19 Dec 2028 |
| NCE | new chemical entity (5 years) | 13 May 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215866 · 001 · RLD | solution, subcutaneous | 2.5MG/0.5ML (2.5MG/0.5ML) | 30 Dec 2041 |
| 215866 · 002 · RLD | solution, subcutaneous | 5MG/0.5ML (5MG/0.5ML) | 30 Dec 2041 |
| 215866 · 003 · RLD | solution, subcutaneous | 7.5MG/0.5ML (7.5MG/0.5ML) | 30 Dec 2041 |
| 215866 · 004 · RLD | solution, subcutaneous | 10MG/0.5ML (10MG/0.5ML) | 30 Dec 2041 |
| 215866 · 005 · RLD | solution, subcutaneous | 12.5MG/0.5ML (12.5MG/0.5ML) | 30 Dec 2041 |
| 215866 · 006 · RLD | solution, subcutaneous | 15MG/0.5ML (15MG/0.5ML) | 30 Dec 2041 |